FDA Recall D-1697-2012

Ben Venue Laboratories Inc · Bedford, OH

Class I — life-threatening Terminated 587 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs, Bedford, OH 44146, NDC 55390-039-10.

Lot / code: Lot #2067134 Exp 5/31/2013, NDC 55390-039-10

Quantity: 797 boxes/10/20 mg vials

Reason for recall

Presence of Particulate Matter

Recall record

Recall number: D-1697-2012
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Nationwide
Recall initiated: 2012-06-26
Classified by FDA Center: 2012-09-26
FDA published: 2012-10-03
Terminated: 2014-02-03
Recalling firm: Ben Venue Laboratories Inc
Firm location: Bedford, OH

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